Our client who provides sterilisation services to many of the world’s largest medical device manufacturers is currently seeking a dynamic and committed Project Commissioning Engineer to support validation activities of existing systems and new installations across the company’s facilities in Europe and Asia. As a Project Commissioning Engineer, you will report directly to the Project Commissioning Manager and will ensure all validations activities meet company and industry regulatory standards.
This position offers full remote working, but travel to the company’s sites across Europe will be expected.
This is a permanent role with an excellent salary and package.
Your new job
Key duties & responsibilities include:
Work in a team to identify and liaise with suppliers to ensure that they are competent and deliver on contractual obligations.
In conjunction with internal and external stakeholders, ensure that User Requirements Specification (URS), Functional & Design Specifications, Risk Assessments, and other GAMP documentation are developed and approved.
Create validation test scripts and protocols as required.
Support and advise project teams and other colleagues on the validation of new equipment, systems, and processes.
To supervise and execute (where appropriate) the validation of automated software systems.
Responsibility in conjunction with the Quality team for supervision of qualification compliance of existing and new systems and regulatory validation requirements.
What are we looking for?
· A degree in Engineering, Science, or another relevant discipline.
· A minimum of three years’ experience in a similar role and ideally within a regulated manufacturing environment.
· Ability to communicate well with stakeholders at all internal and external levels.
· Ability to explain technical requirements to wider audiences (for new suppliers or non-technical colleagues).
· The ability to work with and lead teams.
· Attention to detail.
· Works well under pressure and consistently meets deadlines.
· Commercial awareness.
· Competent in use of MS Word, PowerPoint, Excel
· Experience in using MS Project (desirable)
· Please note that international travel will be required for this role and the amount of travel is project dependant.
Apply for this job now with a Word version of your CV or get in touch with Oliver at firstname.lastname@example.org
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